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UC Davis Health Clinical Studies

A Study to Evaluate an Experimental Tricuspid Valve Repair System (TRILUMINATE Study)

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This research study will test the performance of the experimental tricuspid valve repair system. It will be given with standard of care drug therapy. The study team will compare this experimental treatment to standard of care drug therapy alone. You are being asked to take part in this study because you have moderate or greater tricuspid regurgitation (TR). You have been determined to have symptoms due to heart failure despite treatment. TR occurs when your tricuspid valve does not close properly. This causes blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. The Study consists of two arms: Randomized Arm and a Single Arm. An independent committee will review screening results and randomly assign participants to each treatment group.

Device study
Any, age 18 years or older

A Comparison Study of the Experimental Edwards PASCAL Device and Abbott Mitraclip for Mitral Regurgitation

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This study will test the safety and performance of the Edwards PASCAL Transcatheter Mitral Valve Repair System. It will be compared to the Abbott MitraClip Transcatheter Mitral Valve Repair System in patients with mitral regurgitation. Mitral regurgitation (MR) is a condition when your heart’s mitral valve does not close tightly. This causes blood to flow backwards in your heart. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. There are two major categories of mitral regurgitation: 1) Degenerative Mitral Regurgitation (DMR), also known as Primary MR. This occurs when there is a problem or injury involving the valve or leaflets themselves. 2) Functional Mitral Regurgitation (FMR), also known as Secondary MR. This occurs when the valve itself is normal, but problems with the heart muscle keep the valve leaflets from fully closing. You have been asked to be a part of this study because despite medical therapy for your MR, you have been determined to have symptoms due to heart failure. The PASCAL and MitraClip Systems are designed to reduce the amount of mitral regurgitation without the need for surgery. It is unknown whether the amount of reduction in regurgitation that is achieved using the PASCAL implant system will benefit you. The PASCAL System is an experimental device. This means the PASCAL system has not yet been approved by the FDA for commercial sale. The PASCAL System has been approved for commercial sale in Europe. The MitraClip System is approved in the United States for patients with: - moderate to severe DMR at risk for surgery - symptomatic heart failure with moderate to severe FMR.

Device study, Phase 3
Any, age 18 years or older

A Study of the Long-Term Safety and Effectiveness of Embosphere® PROstate - Post Market Study

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You are being invited to join a research study. This study will collect information about symptom improvement and events related to the Prostatic Artery Embolization (PAE) treatment. This study is for patients who have lower urinary tract symptoms from benign prostatic hyperplasia (BPH). Patients have had treatment with PAE with Embosphere Microspheres. This study device (Embosphere Microspheres) is an FDA approved device that is used at other hospitals but is not currently used at UC Davis. The purpose of this study is to evaluate the long-term effectiveness of PAE with Embosphere Microspheres. As this product is not offered here at UC Davis the sponsor is providing the product for the study. This is considered a post market study as it is already FDA approved. You are invited to be in this study because you have lower urinary tract symptoms from benign prostatic hyperplasia (BPH). Your doctor has scheduled a PAE procedure for you.

Device study, Phase 4
Male, age 18 years or older

ACURATE IDE Study: Safety and Effectiveness of the Experimental Acurate Valve for Transcatheter Aortic Valve Replacement

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This study will test the safety and effectiveness of the experimental ACURATE Valve System. It will be used for transcatheter aortic valve replacement (TAVR). TAVR is a minimally invasive method, using a vein in your leg to implant the device into your heart. This study is for patients with severe native aortic stenosis who are indicated for TAVR. The ACURATE Valve System is an experimental device. This means that the valve is not currently approved for commercial use by the FDA. The ACURATE Valve System consists of pig heart tissue processed by the manufacturer, attached to a delivery system. The valve tissue is sewn onto a metal frame made of nitinol (mostly nickel and titanium). The delivery system is a long tube with the valve attached at one end and a handle attached at the other end to control placement of the valve.

Device study
Any, age -1 years or older

A Study of the Experimental Prevena™ device (Incisional Negative Pressure Wound Therapy) for Soft Tissue Sarcoma Wounds

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Patients with sarcomas (tumor in bone or soft tissue) who receive radiation before surgery have a greater chance of complications in wound healing. This research study will test a wound dressing called Negative Pressure Wound Therapy (NPWT). NPWT is a wound sponge attached to a gentle suction device. It is more effective at preventing infection of the surgical wound than standard dry gauze wound dressing. The Prevena™ device (NPWT) is FDA approved for use on incisions. This will be considered the investigational dressing. The NPWT device is a foam sponge that is placed over the incision after surgery, and provides a low pressure gentle suction on the wound. It is sealed with an adhesive dressing. The traditional standard dry gauze dressing will be considered the control dressing for this study

Device study
Any, age 18 years or older

A Study of Experimental PET Scan for Renal Cell Carcinoma (kidney cancer)

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The current treatment for kidney cancer only benefits some patients. It can be costly and toxic. To check if treatment is working, doctors use computed tomography (CT) and/or magnetic resonance imaging (MRI). This imaging is done approximately two months after cancer treatment. In some cases where treatment is not working, those patients are unnecessarily exposed to toxic treatment. They can then switch to other potentially effective therapy. The purpose of this study is to learn a new way of imaging cancer early during the treatment course (two weeks). This will help determine if the treatment is effective. We will explore the benefit of functional PET technique for earlier prediction of cancer response.

Diagnostic Test study
Any, age 21 to 80 years old

A Study of the Experimental CorMatrix Cor TRICUSPID ECM Device for Tricuspid Valve Replacement

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This study will determine if the experimental Cor TRICUSPID ECM Valve is a safe replacement of your natural Tricuspid Valve. This is an Early Feasibility Study. That means that it is a small study of a new kind of device. It has only been implanted in a limited number of human subjects. There may be less nonclinical information and testing than would be required to start a larger study. The study is designed to gain initial insights into the basic safety and functionality of the study device. Participation in this study will involve placement of the experimental device Cor TRICUSPID ECM Valve. It will replace your dysfunctional tricuspid heart valve. Over time, the design of the CorMatrix Cor TRICUSPID ECM Valve may allow your own cells to grow into and reconstruct the tricuspid valve structure. This will result in long-term tissue repair with your own natural tissue.

Device study
Any, age 1 to 70 years old

ILUMIEN IV: A Study of OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation (OPTIMAL PCI)

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Coronary Stent placement is guided by imaging techniques. The most commonly used technique is Coronary Angiography, which uses x-rays. The doctors in your hospital also use OCT (optical coherence tomography). OCT is an imaging technique. It allows for visualization of the stent and artery wall using light, like having a microspic flashlight placed in your heart artery. The primary purpose of this study is to compare OCT to angiography during coronary stent placement. The physicians participating in this study are experienced users of angiography and OCT in routine clinical practice. There are two phases of the study. The first phase in a roll-in phase. During this time, up to 3 persons at UC Davis will be enrolled who will have the stenting procedure done using OCT. This roll in phase is to show that the physicians can follow the OCT stent guidance procedures. The second phase of the study will enroll persons to be randomized to have the stent placed with angiography or OCT. The study physician will let you know at time of consent if you will be part of the roll-in phase or the randomized phase.

Device study
Any, age 18 years or older

A Study of the Experimental Neuro-Spinal Scaffold™ Device for Complete Thoracic AIS A Spinal Cord Injury

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The purpose of this study is to test the safety and benefit of a new medical device. This device is implanted into the injured spinal cord for a recent spinal cord injury. The procedure to implant the medical device may be added to the usual, standard treatment for spinal cord injury. The study doctor will attempt to perform your surgery as soon as possible. The medical device is experimental and is not approved by the FDA. There is no evidence that the medical device will be of any benefit to you. However, the study will look at whether the new medical device helps improve the medical condition of patients with recent spinal cord injuries.

Device study
Any, age 16 to 70 years old

A Study of the FamilyLink Videoconferencing System and Breastfeeding

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This research study will determine whether viewing your baby while pumping changes the amount and/or content of your breastmilk. We also want to learn if viewing your baby changes your experience with pumping. You are invited to be in this study because you are a mother of a patient in our Neonatal Intensive Care Unit (NICU) who is currently pumping breastmilk. FamilyLink is a videoconferencing software used to view your baby remotely. Participation in this study will involve three sessions pumping breastmilk while using FamilyLink. Three sessions will be done without using FamilyLink. After each session you will complete a short survey and bring your pumped milk into the NICU. Which sessions you use FamilyLink for will be randomly assigned.

Behavioral study
Female, age -1 years or older
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